Status:
COMPLETED
Stenting in Renal Dysfunction Caused by Atherosclerotic Renal Artery Stenosis
Lead Sponsor:
UMC Utrecht
Conditions:
Renal Artery Obstruction
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background: Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatme...
Detailed Description
This is a randomized, multicenter trial of patients with an ostial ARAS and renal failure. Patients will be randomized to: (i)medical treatment consisting of antihypertensive, lipid-lowering and anti...
Eligibility Criteria
Inclusion
- Age \>18 years
- Ostial atherosclerotic renal artery stenosis ≥50% on CTA, MRA or intra-arterial angiography
- Estimated creatinine clearance \<80 ml/min/1.73m2 according to the Cockcroft and Gault formula, on two occasions within one month
Exclusion
- Declined informed consent
- Proven cholesterol embolisation at previous interventions
- Renal artery diameter \<4mm
- Estimated creatinine-clearance \<15ml/min/1.73m2
- Diabetes Mellitus with proteinuria \>3g/24h
- Any known cause of renal failure other than ischemic nephropathy
- Pulmonary oedema in the presence of bilateral renovascular disease in combination with intolerance of ACE-inhibitors/ Angiotensin-II antagonists defined as a fall of estimated creatinine clearance of \>20%
- Malignant hypertension (fundus grade III/IV)
- Myocardial infarction or CVA \<3 months before planned date of inclusion
- Contra-indication for the use of atorvastatin
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00150943
Start Date
June 1 2000
Last Update
April 27 2006
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX